Events

Alerta De Seguridad O Notificaciones De Seguridad para VitreaCore® software versions 6.0 to 6.5 inclusive, including all upgrades (except 6.3.1, 6.4.4 and 6.4.5)

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Vital Images.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2014/002
  • Número del evento
    CON362320
  • Fecha
    2014-01-07
  • Fecha de publicación del evento
    2014-01-07
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON362320?tabName=allTabs
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Risk of patient misdiagnosis or inappropriate treatment due to incorrect image orientation marking. this may occur when loading a study into the 3d viewer in vitreacore, taking a 16-bit secondary capture snapshot of the study and loading this snapshot in a dicom viewer. vital images has provided advice on how to confirm that snapshots are correctly marked.
  • Acción
    Identify affected devices. Ensure members of staff are aware of the advice and guidance detailed in the manufacturer’s Field Safety Notice (FSN). Consider the need to review images taken prior to this notification due to the risk of misdiagnosis and/or inappropriate treatment  Place a copy of the addendum into the instructions for use. Complete and return the manufacturer’s ‘Effectiveness Check’ form. Radiologists Radiographers

Device

VitreaCore® software versions 6.0 to 6.5 inclusive, including all upgrades (except 6.3.1, 6.4.4 a...
  • Modelo / Serial
  • Descripción del producto
    Workstation software for computed tomography systems: VitreaCore® software versions 6.0 to 6.5 inclusive, including all upgrades (except 6.3.1, 6.4.4 and 6.4.5).
  • Manufacturer
    Vital Images

Manufacturer

Vital Images
  • Empresa matriz del fabricante (2017)
    Canon Inc
  • Source
    MHRA